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Associate Director Biostatistics

Company: Larimar Therapeutics
Location: Bala Cynwyd
Posted on: January 16, 2022

Job Description:


About Us:
We are Larimar Therapeutics, based in the Philadelphia area, and committed to discovering and developing therapeutics to dramatically improve the lives of patients with complex rare diseases.
At Larimar we embrace everyone's contribution to our Mission, have fun while working passionately. Our values connect us and ensure we communicate openly, treat each other with respect, help us grow from our successes and failures, and innovate.
If you are searching for a company where urgency, agility, and commitment to science win the day - we welcome you!

Position Summary:
The Associate Director of Biostatistics acts as the statistical lead for multiple clinical studies and/or a clinical development program. This role provides leadership and guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. The Associate Director of Biostatistics participates in regulatory interactions and submissions to the FDA and other regulatory agencies, and contributes to the building of the biometrics group by identifying, developing, and implementing departmental standards, applications, processes, and training.

The responsibilities may include, but are not limited to, the following activities.

Contribute strategically to clinical development plans and regulatory strategies to ensure that the company's clinical programs are optimally designed and executed.
Provide statistical consultations and strategic inputs in terms of drug development for the company's senior management and other staff within the company.
Participate in study/product level tasks including regulatory interactions and filing and ensure statistical integrity; contribute strategically to the supporting projects from the statistics perspective.
Contribute to the study level tasks from statistics perspective, including but not limited to: study design and sample size determination; author/review statistics section in the protocol, SAP and DMC charter; create/review study randomization files; develop TFL shell and specification; review CRFs and other study documentations; active participation in study related meetings.
Perform complicated statistical analyses, and oversee the generation of tables, listings and figures for study reports and manuscripts/posters.
Demonstrate proficiency with SAS statistical procedures, familiarity with specialized statistical software (e.g.,R, S-PLUS, EaSt, nQuery).
Review regulatory documents for accuracy and appropriateness of statistical interpretations
Cultivate internal and external relationships based on trust and respect in anticipation of future working relationships; demonstrated ability to proactively maximize relationships to enable successful collaboration.
Communicate effectively with internal team members, senior management, external experts and regulatory authorities.
Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements.
Lead in developing department standards and research in advanced statistical methodologies
Author/review regulatory documents or scientific publications.
Contribute to project budget/resource planning, re-forecasting, and program milestones.

Education, Experience, Skills and Knowledge:
To be considered for this position you must have a Ph.D. in Statistics, Biostatistics or Mathematics with a minimum of 5 years (minimum 8 years for master's degree) of post-graduate experience in the clinical trials setting in the pharmaceutical industry and comprehensive knowledge of statistical methodology in design and analysis and regulatory requirements relating to clinical development of drugs and biologics. Sound working knowledge with NDA/BLA/MAA activities from a statistics perspective, direct regulatory interaction and inspections, study level work authoring SAP and TFL specification, statistical methods (longitudinal data analyses, Bayesian method, adaptive design, Simulations) is also required, as is familiarity with ICH guideline, FDA/EMA/regulatory authority guidance, also SAS and R; preferably with knowledge in CDISC including SDTM, ADaM and controlled terminologies. You should be adept at outsourcing and managing biostatistical services provided by CRO's/contractors, developing SAS programs to perform planned or ad hoc analyses, contributing or leading development of department SOP's. The best suited candidate will have excellent communication and verbal skills with the ability to translate statistical concepts to program strategies, to prioritize and complete multiple tasks within timelines, maintain flexibility and succeed under pressure situations.

Equal Opportunity Employment
We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live.
Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the employment relationship with all employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes.
. Requirements:

Keywords: Larimar Therapeutics, Philadelphia , Associate Director Biostatistics, Executive , Bala Cynwyd, Pennsylvania

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